Class 2 Device Recall Sedecal SPHF 4.0 Portable XRay System

• Date Initiated by Firm: October 27, 2003
• Date Posted: October 29, 2003
• Recall Status: Terminated on March 24, 2004
• Recall Number: Z-0001-04
• Recall Event ID: 27549
• 510(K)Number: K020436
• Product Classification: unknown device name - Product Code IZL--
• Product: Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain
• Code Information: serial #PK10058
• Recalling Firm/ Manufacturer: Sedecal USA, Inc; 2910 N Arlington Heights Rd; Arlington Heights IL 60004-1551
• For Additional Information Contact: Mr. Devan Moser ; 847-394-6960
• Manufacturer Reason for Recall: A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the SP-HF-4.0 Portable Systems not complying with the U.S. Federal performance standard.
• FDA Determined Cause: Other
• Action: An 'Important Safety Notice' dated 10/27/03 was sent to the one direct account on the same date, informing them of the non-compliances with the performance standard and requesting them to call Sedecal at 800-920-9525 to arrange for the modification of the x-ray unit at no cost to the user.
• Quantity in Commerce: 1 unit
• Distribution: Vermont

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IZL--